Enhancing Patient Ability to Understand and Utilize Complex Information Concerning Medication Self-management
1 other identifier
interventional
286
1 country
1
Brief Summary
The aim of the proposed project is to compare the effectiveness of two strategies designed to enhance patient understanding of medication risks/benefits: (1) Medication Guides, mandated for many medications by the Food and Drug Administration and (2) Drug Facts Boxes, developed by Woloshin and Schwartz to enhance the usability of consumer medication information. The investigators will also assess whether the effectiveness of these communication strategies can be increased by Gist Reasoning Training, which is designed to enhance patients' ability to extract meaningful gist from complex information.The investigators anticipate enrolling 300 individuals with rheumatoid arthritis. The study will use a randomized controlled trial design with four study arms. Data will be collected primarily via self-administered, Internet-based surveys using REDCap. All participants will be followed for 6 months after the completion of baseline data collection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable rheumatoid-arthritis
Started Sep 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedResults Posted
Study results publicly available
January 18, 2020
CompletedJanuary 18, 2020
November 1, 2019
2.3 years
June 27, 2016
October 28, 2019
January 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Classified as Having Made an Informed Decision at 6 Months
Informed decision making is characterized by making a value-consistent decision based on accurate knowledge. Knowledge will be assessed as described under Outcome 2. Values will be assessed using a 10-item scale developed by Fraenkel et al. Scores on this scale can range from 0 to 10, with lower scores reflecting a reluctance to use medications to control disease activity. Participants will be classified as having made an informed choice if they: (1) answered at least 85% of the knowledge items correctly, scored 6 or more on the values scale, and are currently taking one or more DMARDS OR (2) answered 85% of the knowledge items correctly, scored 5 or less on the values measure, and are not currently taking a DMARD. Otherwise, individuals will be classified as not having made an informed choice.
Month 6 Follow-up
Secondary Outcomes (20)
Mean Knowledge of the Risks and Benefits Associated With DMARD Therapy at 6 Months Adjusted for Baseline
Month 6 Follow-up
Mean Values at 6-Months Adjusted for Baseline
Month 6 Follow-up
Mean Gist Reasoning Ability, Lesson Quality at 6 Month Follow-up Adjusted for Baseline
Month 6 Follow-up
Mean Gist Reasoning Ability, Complex Abstraction at 6-Month Follow-up Adjusted for Baseline
Month 6 Follow-up
Mean Satisfaction With Medication Information at 6-Month Follow-up Adjusted for Baseline
Month 6 Follow-up
- +15 more secondary outcomes
Other Outcomes (3)
Patient Interest in Information About Treatment Options: Viewed at Least One Webpage
6 months
Patient Interest in Information About Treatment Options: Number of Pages Viewed
6 months
Percentage of Participants Using a DMARD (Disease-Modifying Antirheumatic Drug) at 6-Month Follow-up
Month 6 Follow-up
Study Arms (4)
Other CMI Only
ACTIVE COMPARATORApproximately 75 participants will be assigned to this study group. Participants will ONLY receive medication guides, or other comparable Consumer Medication Information (CMI), for rheumatoid arthritis medications.
Other CMI & SMART Program
EXPERIMENTALApproximately 75 participants will be assigned to this study group. Participants will receive medication guides, or other comparable Consumer Medication Information (CMI), for rheumatoid arthritis medications AND will be enrolled into the Strategic Memory Advanced Reasoning Training (SMART) Program.
Drug Facts Boxes Only
EXPERIMENTALApproximately 75 participants will be assigned to this study group. Participants will ONLY receive Drug Facts Boxes for rheumatoid arthritis medications.
Drug Facts Boxes & SMART Program
EXPERIMENTALApproximately 75 participants will be assigned to this study group. Participants will receive Drug Facts Boxes for rheumatoid arthritis medicationsAND will be enrolled into the Strategic Memory Advanced Reasoning Training (SMART) Program.
Interventions
The investigators will compare the effectiveness of two types of written prescription drug information targeted for patients: (1) Medication Guides mandated by the Food and Drug Administration, and (2) Drug Facts Boxes, developed by Woloshin and Schwartz.
The investigators will determine if the effectiveness of written medication information can be increased by Gist Reasoning Training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information.
The investigators will compare the effectiveness of two types of written prescription drug information targeted for patients: (1) Medication Guides mandated by the Food and Drug Administration, and (2) Drug Facts Boxes, developed by Woloshin and Schwartz.
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Able to speak and read in English
- Physician confirmed RA define by 1987 American College of Rheumatology criteria
- Moderate or highly active rheumatoid arthritis (assess by Routine Assessment of Patient Index Data 3 (RAPID3) score \> 2.0) and
- Physician indicates patient is a candidate for initiation or escalation of Disease-modifying antirheumatic drug (DMARD) therapy
You may not qualify if:
- \. Hearing or visually impaired
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- The University of Texas at Dallascollaborator
- University of Alabama at Birminghamcollaborator
- University of Texas Southwestern Medical Centercollaborator
- University of Pittsburgh Medical Centercollaborator
- Global Healthy Living Foundationcollaborator
- Dartmouth Collegecollaborator
- Cornell Universitycollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
Blalock SJ, Solow EB, Reyna VF, Keebler M, Carpenter D, Hunt C, Hickey G, Curtis JR, O'Neill K, Chapman SB. Enhancing Patient Understanding of Medication Risks and Benefits. Arthritis Care Res (Hoboken). 2022 Jan;74(1):142-150. doi: 10.1002/acr.24421. Epub 2021 Dec 22.
PMID: 32799397DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susan J. Blalock, PhD
- Organization
- University of North Carolina at Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Susan J Blalock, PhD
UNC
- STUDY DIRECTOR
Caprice Hunt, MPH
UNC
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2016
First Posted
June 30, 2016
Study Start
September 1, 2016
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
January 18, 2020
Results First Posted
January 18, 2020
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- All materials will be made available by 2/15/2020 and will remain available via the website for at least two years.
- Access Criteria
- Completion of a form indicating the name of the requester, contact information, and the research questions the requester plans to address. Completion of this form is only required to ensure that the requester is not a bot.
The investigators will create a web-site to disseminate study findings. Access to the website will not be restricted in any way. The website will provide a link for individuals to obtain a copy of study data. Individuals will be required to complete a form to request the data, indicating their name, contact information, and the research questions they plan to address. The investigators will then provide individuals with a complete, cleaned, deidentified copy of the final Statistical Analysis Software (SAS) dataset and a copy of the study protocol which will include all of the information needed to replicate the analyses or perform secondary analyses. The investigators will use SharePoint to provide these materials to those who request them. The link providing access to study data will appear and be active within nine months following the final year of funding. The reason for not putting the data onto the study website is to enable the investigators to track data usage.